Model Number IPN000320 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2022 |
Event Type
malfunction
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Event Description
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There was no patient involvement.It was reported that the pump alarmed "purge failure." as a result, the pneumatic control system assembly was replaced, and the machine was returned to service.
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Manufacturer Narrative
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(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of purge failure is confirmed.The returned pcs assembly's balloon pressure transducer was faulty, which caused a purge failure alarm.The root cause of this complaint is undetermined.Corrections have been established for this issue as a result of a non-conformance and this device was manufactured prior to the release of those corrections.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.
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Event Description
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There was no patient involvement.It was reported that the pump alarmed "purge failure." as a result, the pneumatic control system assembly was replaced, and the machine was returned to service.
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Search Alerts/Recalls
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